JP2018505189A - コラーゲンおよび微粉化胎盤組織からなる組成物ならびにその調製および使用方法 - Google Patents
コラーゲンおよび微粉化胎盤組織からなる組成物ならびにその調製および使用方法 Download PDFInfo
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- JP2018505189A JP2018505189A JP2017541673A JP2017541673A JP2018505189A JP 2018505189 A JP2018505189 A JP 2018505189A JP 2017541673 A JP2017541673 A JP 2017541673A JP 2017541673 A JP2017541673 A JP 2017541673A JP 2018505189 A JP2018505189 A JP 2018505189A
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- collagen
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- micronized
- placental tissue
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Abstract
Description
水和コラーゲンおよび微粉化胎盤組織成分からなる凝集性かつ柔軟性の組成物が本明細書に記載されている。一態様では、本組成物は、水、コラーゲンおよび微粉化胎盤組織成分を含む。例えば以下に記載されている経路によって好ましい組成物を調製することができる。例えばPCT出願国際公開第2012112410号ならびに米国特許出願公開第2013/0344162号および第2014/0050788号に記載されている微粉化胎盤組織成分からそのような組成物を調製する。これらの出願の開示内容全体が参照により本明細書に明確に組み込まれる。
微粉化胎盤組織を生成するために使用される成分は胎盤由来である。胎盤源は異なってもよい。一態様では、胎盤はヒトなどの哺乳類由来である。限定されるものではないが、ウシおよびブタなどを含む他の動物を本明細書で使用することができる。ヒトの場合、胎盤の回収は病院で行われ、そこでは、帝王切開分娩中に胎盤が回収される。提供者(出産間近の母親を指す)は、移植が可能である最も安全な組織を得るために設計された包括的スクリーニングプロセスを自発的に受ける。スクリーニングプロセスは好ましくは、従来の血清検査を用いて、ヒト免疫不全ウイルス1型および2型に対する(抗HIV−1および抗HIV−2)抗体、B型肝炎ウイルスに対する(抗HBV)抗体、B型肝炎表面抗原(HBsAg)に対する抗体、C型肝炎ウイルスに対する(抗HCV)抗体、ヒトTリンパ球向性ウイルス1型および2型に対する(抗HTLV−I、抗HTLV−II)抗体、CMVおよび梅毒について検査し、ヒトの免疫不全ウイルス1型(HIV−1)およびC型肝炎ウイルス(HCV)については核酸検査を行う。当業者には理解されるように、時間の経過または胎盤成分の使用目的に基づいて、より多くの試験、より少ない試験または異なる試験が望まれたり必要となったりすることがあるため、上記試験の列挙は単なる一例である。
処理センターまたは実験室に到着するとすぐに、出荷物を開封し、出荷用滅菌バッグ/容器がなお密封され、かつ冷却剤の中にあるか、適切な提供者の書類が存在するか、そして、書類上の提供者番号が当該組織を含む出荷用滅菌バッグ上の番号と一致しているかを確認する。次いで、当該組織を含む出荷用滅菌バッグをさらなる処理のために準備が整うまで冷蔵庫に保管する。
さらに処理するために当該組織の準備が整ったら、胎盤組織を処理するために必要な滅菌用品を制御された(すなわち無菌)環境にある中間準備地で組み立て、制御環境への導入のために準備を整える。一態様では、胎盤を室温で処理する。制御環境が製造フードであれば、滅菌用品を開封して、従来の無菌操作を用いてフードの中に置く。制御環境がクリーンルームであれば、滅菌用品を開封して、滅菌ドレープで覆われたカート上に置く。従来の無菌操作を用いて、全ての作業台を1枚の滅菌ドレープで覆い、従来の無菌操作を再度用いて、滅菌用品および処理機器を滅菌ドレープ上に置く。
上記単離された胎盤組織成分を、以下に記載されている技術を用いて化学的に除染することができる。一態様では、羊膜および/または絨毛膜を室温で除染する。一態様では、工程130で生成された羊膜を、次の工程のために滅菌ナルゲン広口ボトルに入れることができる。一態様では、以下の手順を使用して羊膜を洗浄することができる。ナルゲン広口ボトルを無菌的に18%高張生理食塩水で満たし、密閉する(あるいは、上蓋で密閉する)。次いで、この広口ボトルを振盪台の上に置き、30〜90分間撹拌し、これにより、羊膜から夾雑物をさらに除去する。振盪台が重要な環境(例えば、製造フード)内になければ、ナルゲン広口ボトルを制御/無菌環境に戻してから開ける。滅菌鉗子を用いるか、内容物を無菌的にデカントすることにより、18%高張生理食塩水を含むナルゲン広口ボトルから羊膜を穏やかに取り出し、空のナルゲン広口ボトルの中に入れる。次いで、羊膜を含むこの空のナルゲン広口ボトルを予め混合した抗生物質溶液で無菌的に満たす。一態様では、予め混合した抗生物質溶液は、硫酸ストレプトマイシンおよび硫酸ゲンタマイシンなどの抗生物質の混合物からなる。硫酸ポリミキシンBおよびバシトラシンなどの他の抗生物質または現在入手可能であるか将来入手可能な同様の抗生物質も好適である。さらに、羊膜の温度を変化させないように添加の際に抗生物質溶液が室温であることが好ましく、そうでなければ羊膜を損傷しまう。次いで、羊膜および抗生物質を含むこの広口ボトルまたは容器を密閉または閉鎖して振盪台の上に置き、好ましくは60〜90分間撹拌する。抗生物質溶液中の羊膜のそのような振盪または撹拌により、当該組織から夾雑物および細菌をさらに除去する。任意に羊膜を界面活性剤で洗浄することができる。一態様では、羊膜を0.1〜10%、0.1〜5%、0.1〜1%または0.5%のTriton−X洗浄溶液で洗浄することができる。
一態様では、羊膜、絨毛膜、ホウォートンゼリーまたはそれらの任意の組み合わせを処理して組織移植片(すなわち積層体)にすることができ、これをその後に微粉化する。別の態様では、個々の羊膜、絨毛膜、ホウォートンゼリー層を独立して脱水し、その後に単独または成分の混合物として微粉化することができる。一態様では、当該組織(すなわち、個々の膜または移植片)を化学的脱水により脱水した後に凍結乾燥する。一態様では、当該組織に存在する残留する水を実質的(すなわち、90%超、95%超または99%超)または完全に除去する(すなわち、当該組織を脱水する)のに十分な時間および量で羊膜、絨毛膜、および/またはホウォートンゼリーを極性有機溶媒と接触させることにより、化学的脱水工程を行う。溶媒はプロトン性であっても非プロトン性であってもよい。本明細書において有用な極性有機溶媒の例としては、限定されるものではないが、アルコール、ケトン、エーテル、アルデヒドまたはそれらの任意の組み合わせが挙げられる。具体的な非限定的な例としては、DMSO、アセトン、テトラヒドロフラン、エタノール、2−プロパノールまたはそれらの任意の組み合わせが挙げられる。一態様では、胎盤組織を室温で極性有機溶媒と接触させる。さらなる工程は不要であり、以下に述べるように当該組織を直接凍結乾燥することができる。
羊膜、絨毛膜および/またはホウォートンゼリー層を個々または組織移植片の形態で脱水したら、脱水した組織を微粉化する。本微粉化組成物は当該技術分野で知られている機器を用いて生成することができる。例えば、Retsch Oscillating Mill MM400を使用して、本明細書に記載されている微粉化組成物を生成することができる。本微粉化組成物中の材料の粒径も本微粉化組成物の用途によって異なってもよい。一態様では、本微粉化組成物は、500μm未満、400μm未満、300μm未満あるいは25μm〜300μm、25μm〜200μmまたは25μmまたは150μmの粒子を有する。特定の態様では、より大きな直径(例えば、150μm〜350μm)を有する粒子が望ましい。当業者であれば、本発明の微粉化組成物中の材料の粒径および粒度範囲は平均的なものであることが分かるであろう。
胎盤組織を微粉化すると、微粉化胎盤組織成分は水性/ゼラチン状コラーゲンに組み込むことができる状態となる。一態様では、コラーゲンはヒトのコラーゲンであり、好ましい実施形態では、コラーゲンはヒトの胎盤のコラーゲンである。
一態様では、本組成物を皮膚に直接塗布される局所組成物として製剤化することができる。局所投与のための製剤としては、乳濁液、クリーム、水溶液、油、軟膏、パテ、ペースト、ゲル、ローション、乳液および懸濁液を挙げることができる。一態様では、局所組成物は1種以上の界面活性剤および/または乳化剤を含むことができる。
一態様では、本コラーゲンおよび微粉化胎盤組織成分の組成物を調製した後に、本コラーゲンおよび微粉化胎盤組織成分の組成物を特定の寸法を有するモールドに充填することにより、成形された3次元構築物を生成してもよい。
一態様では、本コラーゲンおよび微粉化胎盤組織成分の組成物を調製した後、本コラーゲンおよび微粉化胎盤組織成分の組成物を生体適合性材料および/または装置の1つ以上の側面に塗布して、被覆された装置を作製してもよい。
本明細書に記載されているコラーゲンおよび微粉化胎盤組織成分の組成物を、対象において創傷治癒、損傷した腱の修復および美容用途に関わる数多くの医療用途で使用することができる。本明細書に記載されているコラーゲンおよび微粉化胎盤組織成分の組成物を生体適合性材料および/または装置の被覆のために使用することもできる。
米国特許出願公開第2013/0344162号に記載されているプロセス(その開示内容全体が参照により組み込まれる)によって、本明細書で使用される微粉化胎盤組織成分を生成した。
Claims (30)
- 見かけ上の均質性を有する一体化された混合物であるように、水、可溶性コラーゲンおよび微粉化胎盤組織成分を含む組成物。
- 見かけ上の均質性を有する一体化された混合物であり、その上、凝集性かつ柔軟性の塊であるように、水、コラーゲンおよび微粉化胎盤組織成分を含む組成物。
- 前記微粉化胎盤組織成分は、微粉化羊膜、微粉化絨毛膜、微粉化ホウォートンゼリーまたはそれらの任意の組み合わせを含む、請求項1に記載の組成物。
- 前記微粉化胎盤組織成分は400μm未満の粒径を有する、請求項3に記載の組成物。
- 前記微粉化胎盤組織成分は、羊膜層および絨毛膜層を含む微粉化組織移植片を含み、前記絨毛膜層は前記羊膜層の上に直接積層されており、かつさらに前記羊膜層は露出された基底膜およびインタクトな線維芽細胞成分を有する、請求項1〜4のいずれか1項に記載の組成物。
- 前記微粉化胎盤組織成分は、羊膜層および絨毛膜層を含む微粉化組織移植片を含み、前記絨毛膜層は前記羊膜層の上に直接積層されており、かつさらに前記羊膜層はインタクトな上皮細胞層およびインタクトな線維芽細胞成分を有する、請求項1〜4のいずれか1項に記載の組成物。
- 前記コラーゲンはヒトのコラーゲンである、請求項1〜4のいずれか1項に記載の組成物。
- 前記コラーゲンはヒトの胎盤のコラーゲンである、請求項1〜4のいずれか1項に記載の組成物。
- 前記コラーゲンは約0.1%〜約2%のコラーゲンを含む水性コラーゲン材料である、請求項1〜4のいずれか1項に記載の方法。
- 前記微粉化胎盤組織成分:前記コラーゲンの重量比は約3:1〜約100:1である、請求項1〜4のいずれか1項に記載の組成物。
- 前記微粉化胎盤組織成分:前記コラーゲンの重量比は約100:1〜約300:1である、請求項1〜4のいずれか1項に記載の組成物。
- 前記組成物は生理学的条件下で凝集性かつ柔軟性である、請求項11に記載の組成物。
- 前記生理学的条件は約15℃〜約45℃の温度範囲を含む、請求項12に記載の組成物。
- 前記組成物は、水性/ゼラチン状コラーゲンおよび微粉化胎盤組織成分を含む前駆体組成物を放出することにより得られる、請求項1〜4のいずれか1項に記載の組成物。
- 水性/ゼラチン状コラーゲン塊を凝集性かつ柔軟性の組成物に変換する方法であって、
a.十分な微粉化胎盤組織成分を水性コラーゲン材料に組み込む工程と、
b.前記組成物を凝集性かつ柔軟性の塊に変換するために前記組成物に十分な力および剪断力を加える工程と
を含む方法。 - 前記水性コラーゲン材料は約0.1%〜約2%のコラーゲンを含む、請求項15に記載の方法。
- 前記微粉化胎盤組織成分は、微粉化羊膜、微粉化絨毛膜、微粉化ホウォートンゼリーまたはそれらの任意の組み合わせを含む、請求項15に記載の方法。
- 前記胎盤組織成分は400μm未満の粒径を有する、請求項17に記載の方法。
- 前記微粉化胎盤組織成分は、羊膜層および絨毛膜層を含む微粉化組織移植片を含み、前記絨毛膜層は前記羊膜層の上に直接積層されており、かつさらに前記羊膜層は露出された基底膜およびインタクトな線維芽細胞成分を有する、請求項15〜18のいずれか1項に記載の方法。
- 前記微粉化胎盤組織成分は、羊膜層および絨毛膜層を含む微粉化組織移植片を含み、前記絨毛膜層は前記羊膜層の上に直接積層されており、かつさらに前記羊膜層はインタクトな上皮細胞層およびインタクトな線維芽細胞成分を含む、請求項15〜18のいずれか1項に記載の方法。
- 前記コラーゲンはヒトのコラーゲンである、請求項15〜18のいずれか1項に記載の方法。
- 前記コラーゲンはヒトの胎盤のコラーゲンである、請求項15〜18のいずれか1項に記載の方法。
- 前記微粉化胎盤組織成分:前記コラーゲンの重量比は約100:1〜約300:1である、請求項15〜18のいずれか1項に記載の方法。
- 前記放出される材料は生理学的条件下で凝集性かつ柔軟性である、請求項15〜18のいずれか1項に記載の方法。
- 前記生理学的条件は約15℃〜約45℃の温度範囲を含む、請求項24に記載の方法。
- 前記組成物は、水性/ゼラチン状コラーゲンおよび微粉化胎盤組織成分を含む前駆体組成物を放出することにより得られる、請求項15に記載の方法。
- 創傷治癒における請求項1に記載の組成物の使用。
- 損傷した腱の修復における請求項1に記載の組成物の使用。
- 美容用途における請求項1に記載の組成物の使用
- 生体適合性材料または装置を被覆するための請求項1に記載の組成物の使用。
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